Addressing sex-based disparities in solid organ transplantation in the United States - a conference report.

Solid organ transplantation provides the best treatment for end-stage organ failure, but significant sex-based disparities in transplant access exist. On June 25, 2021, a virtual multidisciplinary conference was convened to address sex-based disparities in transplantation. Common themes contributing to sex-based disparities were noted across kidney, liver, heart, and lung transplantation, specifically the existence of barriers to referral and wait listing for women, the pitfalls of using serum creatinine, the issue of donor/recipient size mismatch, approaches to frailty and a higher prevalence of allosensitization among women. In addition, actionable solutions to improve access to transplantation were identified, including alterations to the current allocation system, surgical interventions on donor organs, and the incorporation of objective frailty metrics into the evaluation process. Key knowledge gaps and high-priority areas for future investigation were also discussed.

Disparities in Unilateral Do Not Resuscitate Order Use During the COVID-19 Pandemic.

OBJECTIVES: A unilateral do-not-resuscitate (UDNR) order is a do-not-resuscitate order placed using clinician judgment which does not require consent from a patient or surrogate. This study assessed how UDNR orders were used during the COVID-19 pandemic. DESIGN: We analyzed a retrospective cross-sectional study of UDNR use at two academic medical centers between April 2020 and April 2021. SETTING: Two academic medical centers in the Chicago metropolitan area. PATIENTS: Patients admitted to an ICU between April 2020 and April 2021 who received vasopressor or inotropic medications to select for patients with high severity of illness. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The 1,473 patients meeting inclusion criteria were 53% male, median age 64 (interquartile range, 54-73), and 38% died during admission or were discharged to hospice. Clinicians placed do not resuscitate orders for 41% of patients ( n = 604/1,473) and UDNR orders for 3% of patients ( n = 51/1,473). The absolute rate of UDNR orders was higher for patients who were primary Spanish speaking (10% Spanish vs 3% English; p ≤ 0.0001), were Hispanic or Latinx (7% Hispanic/Latinx vs 3% Black vs 2% White; p = 0.003), positive for COVID-19 (9% vs 3%; p ≤ 0.0001), or were intubated (5% vs 1%; p = 0.001). In the base multivariable logistic regression model including age, race/ethnicity, primary language spoken, and hospital location, Black race (adjusted odds ratio [aOR], 2.5; 95% CI, 1.3-4.9) and primary Spanish language (aOR, 4.4; 95% CI, 2.1-9.4) had higher odds of UDNR. After adjusting the base model for severity of illness, primary Spanish language remained associated with higher odds of UDNR order (aOR, 2.8; 95% CI, 1.7-4.7). CONCLUSIONS: In this multihospital study, UDNR orders were used more often for primary Spanish-speaking patients during the COVID-19 pandemic, which may be related to communication barriers Spanish-speaking patients and families experience. Further study is needed to assess UDNR use across hospitals and enact interventions to improve potential disparities.

The Bucksbaum Institute for Clinical Excellence and the Doctor-Patient Relationship: Origins, Programs, and Future Directions.

The Bucksbaum Institute for Clinical Excellence at the University of Chicago was established in 2011 with the mission to improve patient care, strengthen the doctor-patient relationship, enhance communication and decision making in health care, and reduce health care disparities. The Bucksbaum Institute supports the development and activities of medical students, junior faculty, and senior clinicians who devote themselves to improving doctor-patient communication and clinical decision making. The institute seeks to enhance the skills of physicians as advisers, counselors, and navigators to help patients make informed decisions when facing complex treatment choices. To achieve its mission, the institute recognizes and supports the activities of physicians who excel in clinical care, supports an array of educational programs, and funds research into the doctor-patient relationship. As the Bucksbaum Institute enters a second decade, its focus will begin to extend beyond the University of Chicago, leveraging alumni and other relationships to improve patient care everywhere.

Ethics of Extracorporeal Membrane Oxygenation under Conventional and Crisis Standards of Care.

Extracorporeal membrane oxygenation (ECMO) is a form of life support for cardiac and/or pulmonary failure with unique ethical challenges compared to other forms of life support. Ethical challenges with ECMO exist when conventional standards of care apply, and are exacerbated during periods of absolute ECMO scarcity when "crisis standards of care" are instituted. When conventional standards of care apply, we propose that it is ethically permissible to withhold placing patients on ECMO for reasons of technical futility or when patients have terminal, short-term prognoses that are untreatable by ECMO. Under crisis standards of care, it is ethically permissible to broaden exclusionary criteria to also withhold ECMO from patients who have a low likelihood of recovery, to maximize the overall number of lives saved. Unilateral withdrawal of ECMO against a patient's preferences is unethical under conventional standards of care, but is ethical under crisis standards of care to increase access to ECMO to others in society. ECMO should only be rationed when true scarcity exists, and allocation protocols should be transparent to the public. When rationing must occur under crisis standards of care, it is imperative that oversight bodies assess for inequities in the allocation of ECMO and make frequent changes to improve any inequities.

Clinician Ethical Perspectives on Extracorporeal Membrane Oxygenation in Practice.

PURPOSE: Extracorporeal membrane oxygenation (ECMO) is an expensive and scarce life sustaining treatment provided to certain critically ill patients. Little is known about the informed consent process for ECMO or clinician viewpoints on ethical complexities related to ECMO in practice. METHODS: We sent a cross-sectional survey to all departments providing ECMO within 7 United States hospitals in January 2021. One clinician from each department completed the 42-item survey representing their department. RESULTS: Fourteen departments within 7 hospitals responded (response rate 78%, N = 14/18). The mean time spent consenting patients or surrogate decision-makers for ECMO varied, from 7.5 minutes (95% CI 5-10) for unstable patients to 20 minutes (95% CI 15-30) for stable patients (p = 0.0001). Few clinician respondents (29%) report patients or surrogate decision-makers always possess informed consent for ECMO. Most departments (92%) have absolute exclusion criteria for ECMO such as older age (43%, cutoffs ranging from 60-75 years), active malignancy (36%), and elevated body mass index (29%). A significant minority of departments (29%) do not always offer the option to withdraw ECMO to patients or surrogate decision-makers. For patients who cannot be liberated from ECMO and are ineligible for heart or lung transplant, 36% of departments would recommend the patient be removed from ECMO and 64% would continue ECMO support. CONCLUSION: Adequate informed consent for ECMO is a major ethical challenge, and the content of these discussions varies. Use of categorical exclusion criteria and withdrawal of ECMO if a patient cannot be liberated from it differ among departments and institutions.

The Use of Slow Codes and Medically Futile Codes in Practice.

CONTEXT: Slow codes, which occur when clinicians symbolically appear to conduct advanced cardiac life support but do not provide full resuscitation efforts, are ethically controversial. OBJECTIVES: To describe the use of slow codes in practice and their association with clinicians' attitudes and moral distress. METHODS: We conducted a cross-sectional survey at Rush University and University of Chicago in January 2020. Participants included physician trainees, attending physicians, nurses, and advanced practice providers who care for critically ill patients. RESULTS: Of the 237 respondents to the survey (31% response rate, n = 237/753), almost half (48%) were internal medicine residents (46% response rate, n = 114/246). Over two-thirds of all respondents (69%) reported caring for a patient where a slow code was performed, with a mean of 1.3 slow codes (SD 1.7) occurring in the past year per participant. A narrow majority of respondents (52%) reported slow codes are ethical if the code is medically futile. Other respondents (46%) reported slow codes are not ethical, with 19% believing no code should be performed and 28% believing a full guideline consistent code should be performed. Most respondents reported moral distress when being required to run (75%), do chest compressions for (80%), or witness (78%) a cardiac resuscitation attempt they believe to be medically futile. CONCLUSION: Slow codes occur in practice, even though many clinicians ethically disagree with their use. The use of cardiac resuscitation attempts in medically futile situations can cause significant moral distress to medical professionals who agree or are forced to participate in them.

Statutes Governing Default Surrogate Decision Making for Mental Health Treatment.

OBJECTIVE: The authors sought to describe state-to-state variations in the scope of statutory authority granted to default surrogates who decide on mental health treatment for incapacitated patients. METHODS: The authors investigated state statutes delineating the powers of default surrogates to make decisions about mental health treatment. Statutes in all 50 U.S. states and the District of Columbia were identified and analyzed independently by three reviewers. Research was conducted from August 2017 to November 2018 and updated in January 2020. RESULTS: State statutes varied in approaches to default surrogate decision making for mental health treatment. Eight states' statutes delegate broad authority to surrogates, whereas 25 states prohibit surrogates from giving consent for specific therapies. Thirteen states are silent on whether surrogates may make decisions. CONCLUSIONS: Heterogeneity among state statutory laws contributes to complexity of treating patients without decisional capacity. This variability encumbers efforts to support surrogates and clinicians and may contribute to health disparities.

Practice Changes at U.S. Transplant Centers After the New Adult Heart Allocation Policy.

BACKGROUND: In October 2018, the U.S. heart allocation system expanded the number of priority "status" tiers from 3 to 6 and added cardiogenic shock requirements for some heart transplant candidates listed with specific types of treatments. OBJECTIVES: This study sought to determine the impact of the new policy on the treatment practices of transplant centers. METHODS: Initial listing data on all adult heart candidates listed from December 1, 2017 to April 30, 2019 were collected from the Scientific Registry of Transplant Recipients. The status-qualifying treatments (or exception requests) and hemodynamic values at listing of a post-policy cohort (December 2018 to April 2019) were compared with a seasonally matched pre-policy cohort (December 2017 to April 2018). Candidates in the pre-policy cohort were reclassified into the new priority system statuses by using treatment, diagnosis, and hemodynamics. RESULTS: Comparing the post-policy cohort (N = 1,567) with the pre-policy cohort (N = 1,606), there were significant increases in listings with extracorporeal membrane oxygenation (+1.2%), intra-aortic balloon pumps (+ 4 %), and exceptions (+ 12%). Listings with low-dose inotropes (-18%) and high-dose inotropes (-3%) significantly decreased. The new priority status distribution had more status 2 (+14%) candidates than expected and fewer status 3 (-5%), status 4 (- 4%) and status 6 (-8%) candidates than expected (p values <0.01 for all comparisons). CONCLUSIONS: After implementation of the new heart allocation policy, transplant centers listed more candidates with extracorporeal membrane oxygenation, intra-aortic balloon pumps, and exception requests and fewer candidates with inotrope therapy than expected, thus leading to significantly more high-priority status listings than anticipated. If these early trends persist, the new allocation system may not function as intended.

Variation in Ventilator Allocation Guidelines by US State During the Coronavirus Disease 2019 Pandemic: A Systematic Review.

Importance: During the coronavirus disease 2019 pandemic, there may be too few ventilators to meet medical demands. It is unknown how many US states have ventilator allocation guidelines and how these state guidelines compare with one another. Objective: To evaluate the number of publicly available US state guidelines for ventilator allocation and the variation in state recommendations for how ventilator allocation decisions should occur and to assess whether unique criteria exist for pediatric patients. Evidence Review: This systematic review evaluated publicly available guidelines about ventilator allocation for all states in the US and in the District of Columbia using department of health websites for each state and internet searches. Documents with any discussion of a process to triage mechanical ventilatory support during a public health emergency were screened for inclusion. Articles were excluded if they did not include specific ventilator allocation recommendations, were in draft status, did not include their state department of health, or were not the most up-to-date guideline. All documents were individually assessed and reassessed by 2 independent reviewers from March 30 to April 2 and May 8 to 10, 2020. Findings: As of May 10, 2020, 26 states had publicly available ventilator guidelines, and 14 states had pediatric guidelines. Use of the Sequential Organ Failure Assessment score in the initial rank of adult patients was recommended in 15 state guidelines (58%), and assessment of limited life expectancy from underlying conditions or comorbidities was included in 6 state guidelines (23%). Priority was recommended for specific groups in the initial evaluation of patients in 6 states (23%) (ie, Illinois, Maryland, Massachusetts, Michigan, Pennsylvania, and Utah). Many states recommended exclusion criteria in adult (11 of 26 states [42%]) and pediatric (10 of 14 states [71%]) ventilator allocation. Withdrawal of mechanical ventilation from a patient to give to another if a shortage occurs was discussed in 22 of 26 adult guidelines (85%) and 9 of 14 pediatric guidelines (64%). Conclusions and Relevance: These findings suggest that although allocation guidelines for mechanical ventilatory support are essential in a public health emergency, only 26 US states provided public guidance on how this allocation should occur. Guidelines among states, including adjacent states, varied significantly and could cause inequity in the allocation of mechanical ventilatory support during a public health emergency, such as the coronavirus disease 2019 pandemic.

Bundled Consent in US Intensive Care Units.

BACKGROUND: Bundled consent, the practice of obtaining anticipatory consent for a predefined set of intensive care unit procedures, increases the rate of informed consent conversations and incorporation of patients' wishes into medical decision-making without sacrificing patients' or surrogates' understanding. However, the adoption rate for this practice in academic and nonacademic centers in the United States is unknown. OBJECTIVE: To determine the national prevalence of use of bundled consent in adult intensive care units and opinions related to bundled consent. METHODS: A random sample of US hospitals with medical/surgical intensive care units was selected from the AHA [American Hospital Association] Guide. One intensive care unit provider (bedside nurse, nurse manager, or physician) from each hospital was asked to self-reportuse of per-procedure consent versus bundled consent, consent rate for intensive care unit procedures, and opinions about bundled consent. RESULTS: Of the 238 hospitals contacted, respondents from 100 (42%) completed the survey; 94% of respondents were nurses. The prevalence of bundled consent use was 15% (95% CI, 9%-24%). Respondents using per-procedure consent were more likely than those using bundled consent to self-report performing invasive procedures without consent. Users of bundled consent unanimously recommended the practice, and 49% of respondents using per-procedure consent reported interest in implementing bundled consent. RESULTS: Bundled consent use is uncommon in academic and nonacademic intensive care units, most likely because of conflicting evidence about the effect on patients and surrogate decision makers. Future work is needed to determine if patients, family members, and providers prefer bundled consent over per-procedure consent.

A Qualitative Analysis of Oncology Patient Awareness of Medication Shortages and Their Preferences for How Shortages Should Be Managed.

PURPOSE: Medication shortages in US hospitals are ongoing, widespread, and frequently involve antineoplastic and supportive medications used in cancer care. The ways shortages are managed and the ways provider-patient communication takes place are heterogeneous, but the related preferences of oncology patients are undefined. This study sought to qualitatively evaluate patient preferences. METHODS: A cross-sectional, semi-structured interview study was conducted from January to June 2019. Participants were adult oncology inpatients who received primary cancer care at the University of Chicago, had undergone treatment within 2 years, and had 1 or more previous hospitalizations during that period. Participants (n = 54) were selected consecutively from alternating hematology and oncology services. The primary outcome was thematic saturation across the domains of awareness of medication shortages, principle preferences regarding decision makers, preferences regarding allocation of therapy drugs, and allocation-related communication. RESULTS: Thematic saturation was reached after 39 participants completed the study procedures (mean age, 59.6 years [standard deviation, 14.5 years]; men made up 61.5% of the study population [mean age, 24 years]; response rate, 72.0%). In all, 18% of participants were aware of institutional medication shortages. Patients preferred having multiple decision makers for allocating medications in the event of a shortage. A majority of patients named oncologists (100%), ethicists (92%), non-oncology physicians (77%), and pharmacists (64%) as their preferred decision makers. Participants favored allocation of drugs based on their efficacy (normalized weighted average, 1.3), and they also favored prioritizing people who were already receiving treatment (1.8), younger patients (2.0), sicker patients (3.1), and those presenting first for treatment (5.3). Most participants preferred preferred disclosure of supportive care medication shortages (74%) and antineoplastic medication shortages (79%) for equivalent substitutions. CONCLUSION: In a tertiary-care center with medication shortages, few oncologic inpatients were aware of shortages. Participants preferred having multiple decision makers involved in principle-driven allocation of scarce medications. Disclosure was preferred when their usual medications needed to be substituted with equivalent alternatives. These preliminary data suggest that preferences do not align with current management practices for medication shortages.

A Cross-Sectional Survey of Medical Trainee Experiences During Medication Shortages.

BACKGROUND: Medication shortages prevent patients from receiving optimal care. Despite the frequency with which medical trainees care for inpatients, no assessment of their experiences in medication shortage management has been performed. OBJECTIVE: We evaluated trainees' experiences managing medication shortages. METHODS: We performed a cross-sectional survey of trainees postgraduate year 2 (PGY-2) and above in medicine, anesthesiology, and emergency medicine departments at 2 academic centers in 2018-2019. Categorical and ordinal assessments evaluated shortage awareness, substitution availability, pharmacy and therapeutics committee-based restrictions, communication, and education. Regressions were performed to determine effect of PGY, department, and institution on responses. RESULTS: A total of 168 of 273 subjects completed the survey (62% response rate). Most (95%, 159 of 168) reported managing medication shortages during training; 51% (86 of 168) described managing clinically relevant shortages daily or weekly. Seventy-seven percent (129 of 168) noted equivalent alternatives were unavailable at least one-quarter of the time, and 43% (72 of 168) reported clinically necessary medications were restricted at least weekly. Fifty-four percent (89 of 168) and 64% (106 of 167) of respondents discussed clinically relevant shortages with supervising physicians or patients "some of the time" or less, respectively. Most respondents (90%, 151 of 168) reported they would benefit from shortage management training, but few (13%, 21 of 168) reported prior training. CONCLUSIONS: Although trainees reported frequent involvement in clinically impactful shortage management, medication shortage communication between trainees and supervising physicians or patients appears sporadic. Medication shortage management training is uncommon but perceived as beneficial.

Practical allocation system for the distribution of specialised care during cellular therapy access scarcity.

Novel cellular therapy techniques promise to cure many haematology patients refractory to other treatment modalities. These therapies are intensive and require referral to and care from specialised providers. In the USA, this pool of providers is not expanding at a rate necessary to meet expected demand; therefore, access scarcity appears forthcoming and is likely to be widespread. To maintain fair access to these scarce and curative therapies, we must prospectively create a just and practical system to distribute care. In this article, we first review previously implemented medical product and personnel allocation systems, examining their applicability to cellular therapy provider shortages to demonstrate that this problem requires a novel approach. We then present an innovative system for allocating cellular therapy access, which accounts for the constraints of distribution during real-world oncology practice by using a combination of the following principles: (1) maximising life-years per personnel time, (2) youngest and robust first, (3) sickest first, (4) first come/first served and (5) instrumental value. We conclude with justifications for the incorporation of these principles and the omission of others, discuss how access can be distributed using this combination, consider cost and review fundamental factors necessary for the practical implementation and maintenance of this system.

The ASBH Approach to Certify Clinical Ethics Consultants Is Both Premature and Inadequate.

In November 2018 the American Society for Bioethics and Humanities (ASBH) administered the first Healthcare Ethics Consultant Certification examination to 138 candidates, 136 of whom (98.5 percent) passed and were "certified" as "healthcare ethics consultants." I believe this certification process is both premature and inadequate. Certification for ethics consultants is premature because, as Kornfeld and Prager state repeatedly in their article in this issue of The Journal of Clinical Ethics, "The Clinician as Clinical Ethics Consultant: An Empirical Method of Study," there is a lack of "empirical data on the nature of the problems that prompt ethics consultation requests and on the functions required to address them." These authors proceed to provide a model for the kind of empirical data collection that is needed. Even more relevant, the ASBH model that certifies clinical ethics consultants is inadequate. First, it is inappropriate for a nonclinical organization such as the ASBH to claim the right to certify a clinical process, ethics consultation, involving patients and health professionals. Second, the current certification process requires only a written examination in contrast to the two-step quality attestation process proposed in 2013 by Eric Kodish, MD, and 11 other senior members of the ASBH, including its then president. Third and most importantly, the eligibility criteria for being certified to work on hospital units and to make clinical recommendations for patients and families are minimal and insufficient. The only stated requirements are a bachelor's degree and 400 hours of healthcare ethics consulting experience. By contrast, practicing physicians and nurses train for many years to gain clinical experience that enables them to apply clinical ethical standards in the care and management of all inpatients and outpatients, not just the small percent for whom an ethics consultation is requested.